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Recruiting NCT07080723

Algorithm Guided Treatment Versus Treatment as Usual (TAU) for Patients With Treatment Resistant Depression

Phase IV Interventional Treatment Resistant Depression (TRD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Algorithm guided treatment (AGT), Treatment as usual (TAU).
Who it may be relevant to
Registry conditions: Treatment Resistant Depression (TRD). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The trial utilizes a pragmatic, randomized, open label design with two parallel arms. Participants aged 18-65 with a diagnosis of unipolar depressive disorder and without stable remission in the past 12 months are randomized 1:1 to receive either algorithm guided treatment (AGT) or treatment as usual (TAU). The AGT approach incorporates pre-defined treatment steps, critical decision points, and "if-then" rules based on symptom response. It leverages prior treatment history, current symptomatology, and tolerability profiles to personalize the therapeutic sequence and reduce treatment inertia. In contrast, TAU reflects standard clinical practice, where treatment decisions are left to clinician discretion without algorithmic structure. The primary objective of the study is to determine whether AGT leads to a greater reduction in depressive symptoms over a 12-week treatment period, as measured by the 6-item Hamilton Depression Rating Scale (HAMD-6). Secondary objectives include evaluating cognitive and psychosocial functioning, suicide risk, treatment adherence, tolerability, number of medication changes, and long-term outcomes at a 24-week follow-up, providing insights into the longer-term trajectory of TRD management.

Detailed description

The study period consists of 12 weeks in the randomized phase and 12-week extended follow up period during which all participants are monitored and treated at the clinician's discretion. After baseline, study visits are planned at 4, 8, 12 and 24 weeks.

Interventions

  • Other Algorithm guided treatment (AGT)
    AGTs consist of strategies (which treatments to use), tactics (how to implement each treatment) and treatment steps (in what order to implement the different treatments). Furthermore, AGTs also define critical decision points during the treatment at which the effects of a certain treatment are assessed and based on this assessment recommend specific treatment revisions according to preset "if-then rules." This is most often done by implementing measurement-based care.
  • Other Treatment as usual (TAU)
    TAU includes the standard clinical care for patients with TRD as determined by a senior consultant.

Primary outcome measures

  • Hamilton Depression Scale, 6 item version (HAMD-6) [Time frame: From baseline to end of study (12 weeks)]
Secondary outcome measures (12)
  • HAMD-17 [Time frame: Up to 24 weeks]
  • HAMD-6 [Time frame: Up to 24 weeks]
  • UKU [Time frame: Up to 24 weeks]
  • SCIP [Time frame: Up to 12 weeks]
  • FAST [Time frame: Up to 12 weeks]
  • COBRA [Time frame: Up to 12 weeks]
  • CGI [Time frame: Up to 12 weeks]
  • C-SSRS [Time frame: Up to 12 weeks]
  • Between-groups difference in proportion of responders and remitters in HAMD-6 score [Time frame: Week 8 and 12]
  • Between-group differences in reason for all cause treatment discontinuation [Time frame: Up to 24 weeks]
  • Between-group differences in time to all cause treatment discontinuation [Time frame: Up to 24 weeks]
  • Between-group differences in number of changes in treatment strategies [Time frame: Up to 12 weeks]

Eligibility criteria

Inclusion criteria

  • A diagnosis of unipolar depressive disorder according to ICD-10 based on documented completion of the Mini International Neuropsychiatric Interview, version 7.0.2 (MINI 7.0.2) at Screening and confirmed by medical records or a healthcare professional.
  • Have not achieved stable remission of depression in 12 months at investigator's clinical assessment.
  • Severity of depression: A score of at least 21 on the self-reported Major Depression Inventory (MDI).
  • Age criteria: Subjects must be at least 18 years old and below 65 at the time of randomization.
  • Signed document of informed consent.
  • The participant is an outpatient.
  • No significant change in medical treatment in the last 4 weeks before screening visit.
  • The patient is pharmacologically treated for depression.

Exclusion criteria

  • A diagnosis of dementia.
  • Substance misuse influencing study participation as judged by the investigator.
  • High risk of non-adherence at the investigator's discretion.
  • Not understanding the Danish language as judged by the investigator.
  • Suicidality according to C-SSRS with a positive response to question 4 or 5 within the last three months or upon investigator's discretion.
  • Medical conditions such as cancer, kidney failure, epilepsy, deep brain stimulation device, or other medical conditions interfering with study the outcome and safety as judged by investigator's discretion.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • Aalborg University Hospital — Aalborg

Identifiers

NCT: NCT07080723 · N-20250007

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗